GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161379
• Other study ID #: J1756
• Secondary ID: IRB00130075
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2018
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have histologically proven pancreatic cancer that is borderline resectable
• No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
• Age >18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
• Woman of child bearing potential must have a negative pregnancy test.
• Must use an acceptable form of birth control while on study.
• Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Had major surgery within the last 28 days
• Had an investigational drug or device within the past 28 days
• Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
• Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
• Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
• Other cancer diagnosis requiring treatment within two years
• History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
• Patients receiving growth factors within the last 14 days.
• Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
• Pregnant or breastfeeding.
• Have known history of infection with HIV, hepatitis B, or hepatitis C.
• Unwilling or unable to follow the study schedule for any reason.
• Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
• Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
• Nivolumab
Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
• GVAX Pancreas Vaccine
Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.

Radiation:
• Stereotactic Body Radiation (SBRT)
SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD8 count (cells/mm^3) in the tumor microenvironment	Whether the CD8 count in the tumor microenvironment is higher for patients with BR-PDAC treated with neoadjuvant chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy as compared to archived samples from patients treated with FOLFIRINOX and SBRT.	4 years
Secondary	Pathologic complete response (pCR) rate at surgical resection	Pathologic complete response (pCR) rate at surgical resection of BR-PDAC treated with neoadjuvant sequential chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy.	4 years